Two phase III trials met their primary endpoints, showing that 25 mg of oral remibrutinib twice daily may be effective at improving disease activity scores in adult patients with chronic spontaneous urticaria, according to a press release from Novartis. Researchers explained that remibrutinib, a selective Bruton’s tyrosine kinase (BTK) inhibitor, may be capable of blocking the BTK cascade to prevent the release of a histamine that causes itchiness, hives, welts, and swelling. In two randomized, double-blind, placebo-controlled phase III studies—REMIX-1 (ClinicalTrials.gov identifier NCT05030311) and REMIX-2 (NCT05032157)—the researchers demonstrated that remibrutinib may offer sustained disease control for up to at least 12 weeks compared with standard treatments such as first-line H1-antihistamines. The researchers reported that the patients involved in both studies will be given the opportunity to participate in a long-term extension of the trial. “These positive … results from the phase III REMIX studies confirm that remibrutinib [may] be a first-in-class oral treatment for [patients] with chronic spontaneous urticaria whose symptoms are refractory despite use of antihistamines,” concluded Shreeram Aradhye, MD, President of Global Drug Development and Chief Medical Officer of Novartis.
August 15, 2023